Hands-on Support for Clinical Studies in Stockholm – Gotland

Karolin­ska Trial Alliance (KTA) is a pro­fes­sional Clin­i­cal Research Cen­ter at Karolin­ska Uni­ver­sity Hos­pi­tal in Stock­holm, sup­ported by Stock­holm County Coun­cil (SLL) and the Karolin­ska Insti­tute (KI). KTA is highly spe­cial­ized and has a com­pre­hen­sive knowl­edge within the field and gives hands-​on sup­port for clin­i­cal research to opti­mize the process of con­duct­ing clin­i­cal trials.

KTA con­sists of three units which sup­port con­duct of clin­i­cal tri­als cov­er­ing all phases (I-​IV). KTA has the unique oppor­tu­nity to coop­er­ate with hos­pi­tals and clin­ics within the entire Stock­holm region which includes access to the exten­sive resources of one of the lead­ing uni­ver­sity hos­pi­tals in Europe as well as to the Karolin­ska Institute’s world-​leading researchers.

Our inter­play with the indus­try, researchers and physi­cians range from sin­gle assign­ments to long term collaborations.

Cov­er­ing the Com­plete Clin­i­cal Trial Process

KTA stream­lines the clin­i­cal trial process in order to reduce time and cost of clin­i­cal research. The busi­ness model allows clients to choose and mix ser­vices accord­ing to their spe­cific needs or alter­na­tively choose a com­plete study con­cept pack­age in which KTA is involved from start to finish.

KTA Phase I con­ducts clin­i­cal tri­als for the phar­ma­ceu­ti­cal and med-​tech indus­try and for aca­d­e­mic researchers. The Phase 1 Unit has 16 beds and expe­ri­enced GCP-​trained per­son­nel to carry out clin­i­cal stud­ies from first-​in-​man to proof of con­cept stud­ies. The core com­pe­tence includes first-​in-​man admin­is­tra­tion of inves­ti­ga­tional prod­ucts includ­ing vac­cines, (SAD, MAD, PET, PET-​CT and MRI), bioequivalence/​bioavailability– stud­ies, urine catheter­i­za­tion– stud­ies and biopsy studies. (read more…)

KTA Sup­port pro­vides admin­is­tra­tive assis­tance for the imple­men­ta­tion of aca­d­e­mic clin­i­cal tri­als as well as for the med­ical indus­try. The knowl­edge and expe­ri­ence within the field of clin­i­cal research is pro­found and wide rang­ing. KTA Sup­port offers tailor-​made sup­port from the idea through­out the entire study process, specif­i­cally designed to fit our clients’ requirements. (read more…)

KTA Prim con­ducts open-​care stud­ies in phase II-​IV with the inten­sion to facil­i­tate for the med­ical indus­try, for the acad­emy and for the open health care in Stock­holm to per­form clin­i­cal tri­als as well as to pro­vide bet­ter options for patients to par­tic­i­pate. KTA Prim can achieve the tar­get by being an effi­cient and pro­fes­sional orga­ni­za­tion and by actively work­ing on reduc­ing the bot­tle­necks gen­er­ally occur­ring when per­form­ing clin­i­cal trials. (read more…)

Study Admin­is­tra­tion

Study related admin­is­tra­tion is han­dled by pro­fes­sional and well edu­cated staff. KTA works accord­ing to spe­cific rou­tines and adapted IT-​solutions for opti­mal effi­ciency. The phi­los­o­phy is to keep a high ser­vice level in all rela­tions, i.e. human test sub­jects, pri­mary health care con­tacts, the research team, clin­ics, inves­ti­ga­tors and sponsors.

Safety

KTA works accord­ing to pre­cise stan­dard oper­at­ing pro­ce­dures (SOPs) and effi­cient rou­tines and has ded­i­cated recourses respon­si­ble for inter­nal QA-​systems.

Patient Recruit­ment

Recruit­ment of human sub­jects is quite often an issue when per­form­ing clin­i­cal stud­ies. KTA has a high recruit­ment capac­ity and resources to include large patient groups in tri­als. The meth­ods of recruit­ing are cus­tomized to the spe­cific study and tar­get group. Recruit­ment is often car­ried out in close con­tact with the Pri­mary Health Care, hos­pi­tal clin­ics or other exter­nal col­lab­o­ra­tion partners.